NIPH Clinical Trials Search

UMIN ID: UMIN000002073

Registered date:01/07/2009

Phase II study of combination therapy of cisplatin suspension in lipiodol and 5-fluorouracil hepatic arterial infusion for advanced HCC

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedHepatocellular carcinoma
Date of first enrollment2007/05/01
Target sample size50
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)hospitalization therapy administration via the implanted port of Cisplatin/lipiodol suspension(50mg/body,ia,day1,8) and 5-FU(1250mg/body/day, cia day1-5,8-12) into the hepatic artery every two weeks. outpatient therapy : The case that chemotherapy by the hospitalization finished,leaves the hospital if possible. Administration via the implanted port of Cisplatin/lipiodol suspension(10~50mg/body,ia,day1)and 5-FU(500~1250mg/body/day,cia,day1-5)into the hepatic artery every two weeks.Repeat 10 courses.


Primary OutcomeProgrssion free survival
Secondary OutcomeOverall survival response evaluation complicasion

Key inclusion & exclusion criteria

Age minimum30years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteria1.previous chemotherapy or TAE 2.Previous operation or RFA or PEIT within one year 3.Extrahepatic metastasis or nodes metastasis 4.Concurrent infections(without hepatitis virus) 5.Active double cancers 6.Medical history of severe hypersensitivity. 7.Pregnant,lacting women or women with suspected pregnancy. 8.Inappropriate patients for this study judged by physicians.

Related Information


public contact
Name Hiroaki Nagamatsu
Address 540-2,Takatsuka,Yame-city,Fukuoka,834-0034 Japan
Telephone 0943-23-4131
Affiliation Yame General Hospital Department of Gastroenterology and Hepatology
scientific contact
Name Michio Sata
Address 67,Asahi-machi,kurume-city,Fukuoka,830-0011,Japan Japan
Telephone 0942-31-7561
Affiliation Kurume University School of Medicine Division of Gastroenterology